Knee Injury Decision (KID)

Clinical Criteria for Decision Support Regarding Emergency Radiography for Knee Acute Traumatism in Order to Identify Bone Fracture Among Children.

At this time, there is no standardization for knee trauma care in children. Each physician is free to resort or not to radiography to verify or dispel bone fracture, depending on radiographic device availability. This decision is based on trauma severity, clinical features, and physician experience.

Knee traumatisms are a common reason of consultation. In emergency departments, radiographic use is widespread for those traumatisms, but not in private practice.

Most of those knee traumatisms includes soft tissue lesion, for which radiography gives no details. Yet, radiography exposes bone fracture which may require a specific orthopaedic care. Then, it seems beneficial to highlight simple and reproducible clinical criteria in order to identify severe knee traumatisms, requiring radiography to assess bone fracture.

Those criteria should have a sensibility close to 1, and the highest specificity. Such criteria could significantly decrease the number of radiography thus irradiation, emergencies waiting time, and consultation expenses without missing bone fracture.

Ottawa knee rules for adults are: age 55 years older, tenderness at head of fibula, isolated tenderness of patella inability to flex to 90°, inability to bear weight on 4 steps both immediately and in the emergency department. Presence of one of those criteria required front and profile radiography to assess bone fracture.

However, few studies have been conducted among children, and they do not confirm the use of those criteria targeting fracture screening. Data are contradictory and they do not allow concluding that such criteria could be of benefit for children. Moreover, studies only consider adults clinical criteria. This study would be the first to implement specific paediatric criteria, which make this study original.

Study Overview

• Status: Unknown
• Conditions: Bone Fracture; Knee Trauma

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hospices Civils de Lyon, HFME. 32 Avenue Doyen Jean Lépine
    • Contact: Karine CORREARD, MD; Phone Number: +33 (0)4 27 85 56 49; Email: anne-karine.correard-darne@chu-lyon.fr
    • Contact: Julien BERTHILLER, Clinical project manager; Phone Number: +33 (0)4 27 85 63 01; Email: julien.berthiller@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with Knee traumatism at HFME hospital

Description

Inclusion Criteria:

• Age range from 1 to 17 years old included
• Knee traumatism (distal third of femur and proximal third of tibia/fibula)
• Traumatism not older than 7 days

Exclusion Criteria:

• Isolated knee wound
• Loss of awareness
• Paraplegia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical criteria sensitivity	sensitivity will be evaluated for each clinical criterion, with the radiographic gold standard. Sensitivity will be compared by Mc Nemar paired test, or by Fischer exact test if Mc Nemar test conditions are not fulfilled.	when radiography results are available (day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
criteria specificity	specificity will be evaluated for each clinical criterion, with the radiographic gold standard. Specificity will be compared by Mc Nemar paired test, or by Fischer exact test if Mc Nemar test conditions are not fulfilled	when radiography results are available, at inclusion day (day 1)
Positive and negative predictive values		when radiography results are available, at inclusion day (day 1)
Radiographic use reduction	The number of radiographic use will be measure to identify any variation in this procedure.	when radiography use is determined

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Karine CORREARD, MD, Hospices Civils de Lyon, HFME

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 2, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: children; knee; fracture; decision making; clinical criteria
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 69HCL16_0518